Efficacy Evaluation of Positive End-expiratory Pressure in Children Undergoing Mechanical Ventilation Using Supraglottic Airway Device

NCT ID: NCT05275283

Last Updated: 2022-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-03

Study Completion Date

2023-12-30

Brief Summary

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The aim of this study is to determine whether application of positive end-expiratory pressure (PEEP) improves respiratory data including respiratory compliance in children who receive positive pressure ventilation using supraglottic airway device (SAD).

Detailed Description

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Conditions

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Positive End Expiratory Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Control group

Applying tidal volume 7 ml/kg without PEEP

Group Type NO_INTERVENTION

No interventions assigned to this group

PEEP group

Applying tidal volume 7 ml/kg with 6 cmH2O of PEEP

Group Type EXPERIMENTAL

PEEP

Intervention Type OTHER

6 cmH2O of PEEP

Interventions

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PEEP

6 cmH2O of PEEP

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pediatric patients under 6 years of age who are scheduled simple operation under general anesthesia
* SAD was used for mechanical ventilation

Exclusion Criteria

* Abdominal distension, risk of pulmonary aspiration
* Bronchopulmonary dysplasia/respiratory distress syndrome
* Pneumothorax
* Airway surgery
* Thoracic surgery or laparotomy
* Surgery under prone position
Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hee-Soo Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hee-Soo Kim

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hee-Soo Kim, MD, PhD

Role: CONTACT

02-2072-3659 ext. 82

Facility Contacts

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Hee-Soo Kim, MD.PhD

Role: primary

08201052878006

Ji-Hyun LEE, MD. PhD

Role: backup

82-2-2072-3661

Other Identifiers

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2111-073-1272

Identifier Type: -

Identifier Source: org_study_id

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